The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015:
Summary of PMA Originals & Supplements Approved
- Originals: 9
- Supplements: 133
Summary of PMA Originals Under Review
- Total Under Review: 58
- Total Active: 32
- Total On Hold: 26
Summary of PMA Supplements Under Review
- Total Under Review: 597
- Total Active: 433
- Total On Hold: 164
Summary of All PMA Submissions
- Originals: 7
- Supplements: 74
Summary of PMA Supplement PMA Approval/Denial Decision Times
- Number of Approvals: 133
- Number of Denials: 0
- Average Days Fr Receipt to Decision (Total Time): 161.5
- FDA Time: 97.9 Days
- MFR Time: 63.6 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P150003 10/2/15 |
SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter in lesions ≤34 mm in length. |
| P150013 10/2/15 |
PD-L1 IHC 22C3 pharmDx | Dako North America, Inc. Carpinteria, CA 93013 |
Approval for the PD-L1 IHC 22C3 pharmDx. This device is indicated for the following: PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 Antibody intended for use in the detection of PD-L1protein in formalin fixed, paraffin embedded (FFPE) Non-Small Cell Lung Cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. The specimen should be considered PD-L1 positive if TPS ≥50% of the viable tumor cells exhibit membrane staining at any intensity. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab). |
| P150014 10/14/15 |
cobas® HBV | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for the cobas HBV. This device is indicated for: cobas HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas HBV must be interpreted within the context of all relevant clinical and laboratory findings. The cobas HBV is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection. |
| P150015 10/14/15 |
cobas® HCV | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for the cobas HCV. This device is indicated for: cobas HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay. cobas HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. cobas HCV is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings. cobas HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products. Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used. |
| P150025 10/9/15 |
PD-L1 IHC 28-8 pharmDx | Dako North America, Inc. Carpinteria, CA 93013 |
Approval for the PD-L1 IHC 28-8 Pharmdx. This device is indicated for the following: 1) PD-L1 IHC 28-8 pharmDx is a qualitative immunohisto-chemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48; 2) PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity; and 3) PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO (nivolumab). |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P820003/S132 10/19/15 180-Day |
Symbios, Synergyst | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P850051/S082 10/19/15 180-Day |
Activitrax, Legend, Micro Minix, Minix, Premier, Prevail, Vitatron Legacy |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P860057/S127 10/19/15 135-Day |
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprostheses |
Edwards Lifesciences, LLC. Irvine, CA 92614 |
Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier. |
| P890003/S326 10/19/15 180-Day |
Remote Control Software for the 2090 Programmer, Analyzer Software, Application Software, Elite II, Elite, Lead Analysis Device, Lead Analyzer, Minuet, Preva, Prodigy, Programmer Software, SessionSync Feature, Synergyst II, Thera, Vitatron Legacy, Vitatron Visa |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P890003/S336 10/7/15 Real-Time |
CareLink Express Monitor, Cardiosight Reader, CareLink Home Monitor | Medtronic Inc. Mounds View, MN 55112 |
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices. |
| P900061/S133 10/19/15 180-Day |
Medtronic GEM ICD, Medtronic Jewel ICD, Medtronic Jewel Plus ICD, Medtronic Micro Jewel ICD, Medtronic PCD Tachyarrhythmia Control System |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P910001/S078 10/20/15 Real-Time |
CVX-300/CVX-300-P Excimer Laser System | Spectranetics, Inc. Colorado Springs, CO 80921 |
Approval for a minor design change to the Anti-Reflective coating that is applied to the laser vessel windows. |
| P920015/S146 10/19/15 180-Day |
Medtronic PCD Tachyarrhythmia Control System | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P930022/S017 10/19/15 180-Day |
Legend Plus | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P960004/S059 10/8/15 180-Day |
FINELINE II Sterox and Sterox EZ Endocardial Pacing Leads | Boston Scientific Corporation St Paul, MN 55112 |
Approval for the following: 1) A sterilization process change from Oxyfume to 100% Ethylene Oxide; 2) Drug specification changes; 3) Labeling changes; 4) To finish remaining 3 months of Lot Release Study for passive fixation leads as non-clinical post approval study; 4) Manufacturing changes to reduce elution variation; 5) To update active fixation batch release study protocol to implement new manufacturing changes; and 6) To complete 12 month Lot Release Study as non-clinical post approval study. |
| P960040/S354 10/2/15 Real-Time |
DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for design changes to the NG3 and NG2.5 high voltage capacitors for the devices. |
| P960043/S090 10/9/15 180-Day |
Perclose ProGlide Suture-Mediated Closure System | Abbott Vascular Temecula, CA 92591 |
Approval for new manufacturing sites located at Abbott Vascular, Inc., in Tipperary Ireland, and Synergy Health Ireland Ltd., in Offaly, Ireland. |
| P970003/S183 10/28/15 Real-Time |
VNS Therapy System, VNS Therapy Programming Software | Cyberonics, Inc. Houston, TX 77058 |
Approval for the introduction of the Motion CL910 and minor modifications and enhancements to the VNS Therapy programming software Model 250 Version 11.0.4. |
| P970008/S065 10/29/15 180-Day |
Urologix Targis System for the Treatment of BPH | Urologix, Inc. Minneapolis, MN 55447 |
Approval for a new manufacturing site located at Spectrum Plastics Group in Minneapolis, Minnesota. |
| N970012/S113 10/14/15 Special |
AMS 700™ and Ambicor Inflatable Penile Prosthesis | Boston Scientific Minnetonka, MN 55343 |
Approval for changes in quality controls that add inspection steps to the blunt needle accessory. |
| P970012/S096 10/19/15 180-Day |
Application Software, Kappa 400 | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P970031/S050 10/21/15 Special |
Freestyle Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for the addition of a precaution to instructions for use labeling. |
| P980016/S514 10/19/15 180-Day |
Evera, GEM, Intrinsic, Marquis, Maximo, Protecta, RVLIA, Secura, Virtuoso | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P980016/S547 10/7/15 Real-Time |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, DDBB1D1, DDBB1D4; Evera XT VR ICD Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD | Medtronic Inc. Mounds View, MN 55112 |
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices. |
| P980016/S548 10/29/15 180-Day |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic Inc. Mounds View, MN 55112 |
Approval for three new alternate ICs to be used in the devices. |
| P980022/S140 10/2/15 135-Day |
Paradigm REAL-Time System, Paradigm REAL-Time Revel System Guardian REAL-Time System, MiniLink REAL-Time System, iPro Recorder CGMS System, iPro2 Professional CGM System |
Medtronic MiniMed Northridge, CA 91325 |
Approval for adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (GOx) performed by the supplier for use in the sponsor’s Enlite Sensor (Model: MMT-7008) and Sof-Sensor (Models: MMT-7002 and MMT-7003) Devices. The Enlite Sensor is a component of the MiniMed 530G System. The Sof-Sensor is a component of the Paradigm REAL-Time, Paradigm REALTime Revel, Guardian REAL-Time, MiniLink REAL-Time, IPro Recorder and IPro2 Professional Continuous Glucose Monitoring systems. |
| P980023/S070 10/29/15 180-Day |
Protego DF-1 Lead Family | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the trade name change of the currently marketed Linoxsmart Lead Family to the Protego DF-1 Lead Family. |
| P980035/S404 10/19/15 180-Day |
Adapta, Versa, Sensia, Advisa, Application Software, AT500 DDDRP Pacing System, EnPulse, Kappa, Relia | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P980035/S437 10/7/15 Real-Time |
Advisa DR IPG, Advisa SR MRI IPG | Medtronic Inc. Mounds View, MN 55112 |
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices. |
| P980050/S097 10/19/15 180-Day |
Application Software, Jewel AF | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P990001/S119 10/19/15 180-Day |
Application Software, ProVit Software, Vitatron C20, Vitatron C60, Vitatron T20, Vitatron T60 | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P000053/S061 10/14/15 Special |
AMS 800™ Urinary Control System | Boston Scientific Minnetonka, MN 55343 |
Approval for changes in quality controls that add inspection steps to the blunt needle accessory. |
| P010012/S399 10/2/15 Real-Time |
DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for design changes to the NG3 and NG2.5 high voltage capacitors for the devices. |
| P010013/S066 10/27/15 Real-Time |
NovaSure Impedance Controlled Endometrial Ablation System. | Hologic, Inc. Marlborough, MA 01752 |
Approval for software changes to the NovaSure Model 10 Radiofrequency Controller. |
| P010015/S255 10/19/15 180-Day |
Application Software, Consulta, InSync, Syncra, Viva | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P010015/S279 10/7/15 Real-Time |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic Inc. Mounds View, MN 55112 |
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices. |
| P010013/S065 10/15/15 180-Day |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Approval of the following changes to the post-approval study to reflect the FDA approval of the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Essure. |
| P010031/S478 10/19/15 180-Day |
Application Software, Brava, Concerto, Consulta, InSync, Maximo II, Protecta, RV Lead Integrity Alert (RVLIA), Viva Quad |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P010031/S510 10/7/15 Real-Time |
Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic Inc. Mounds View, MN 55112 |
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices. |
| P010031/S511 10/29/15 180-Day |
Brava CRT-D, Brava CRT-D, Brava Quad CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic Inc. Mounds View, MN 55112 |
Approval for three new alternate Integrated Circuits to be used in the devices. |
| P020050/S024 10/15/15 Real-Time |
ALLEGRETTO Wave Eye-Q Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 66134 |
Approval for labeling revisions to address design change. |
| P030011/S033 10/22/15 Real-Time |
SynCardia temporary Total Artificial Heart (TAH-t) System | SynCardia Systems, Inc. Tucson, AZ 85713 |
Approval for a material change to the driveline tubing of the Freedom Driver System. |
| P030054/S290 10/5/15 Real-Time |
Quartet Family of CRT Leads | St. Jude Medical Sylmar, CA 91342 |
Approval for 1458QL and 1456Q quadripolar LV leads. |
| P040002/S055 10/7/15 Real-Time |
AFX Endovascular AAA System | Endologix, Inc. Irvine, CA 92618 |
Approval for changes to the AFX bifurcated delivery system. |
| P040003/S016 10/5/15 180-Day |
ExAblate Magnetic Resonance Guided Focused Ultrasound System | Insightec Dallas, TX 75244 |
Approval for changes to the software of the ExAblate System including enabling movement of the transducer in the anterior and posterior direction. The modified device is referred to as the ExAblate 2100 V1.1 with software version 6.5. |
| P040037/S081 10/14/15 180-Day |
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86005 |
Approval for a Post-Approval Study labeling update regarding revisions to the Instructions for Use to include the final study results for the RELINE Extended Follow-Up Study. |
| P040047/S038 10/28/15 135-Day |
Coaptite Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process. |
| P050007/S033 10/9/15 180-Day |
StarClose SE Vascular Closure System | Abbott Vascular Temcula, CA 92591 |
Approval for manufacturing sites located at Abbott Vascular, Inc., in Tipperary Ireland, and Synergy Health Ireland Ltd., in Offaly Ireland. |
| P050033/S020 10/22/15 Special |
Hydrelle | Anika Therapeutics, Incorporated Bedford, MA 01730 |
Approval for labeling modifications, as requested in FDA’s letter to manufacturers marketing soft tissue filler implants about the risks associated with vascular injection. |
| P050037/S056 10/28/15 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process. |
| P050047/S048 10/6/15 Real-Time |
Juvéderm Hyaluronate Gel Implants | Allergan Irvine, CA 92623 |
Approval for an improvement to the method used to measure HA content of final JUVÉDERM and VOLUMA XC products during batch release. |
| P050052/S062 10/28/15 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Approval for the implementation of an automated visual inspection system that replaces a manual visual inspection process. |
| P060006/070 10/23/15 Real-Time |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for labeling changes regarding Magnetic Resonance Compatibility and removal of the flushing needle from the product packaging. |
| P060011/S007 10/15/15 135-Day |
Rayner C-Flex, C-flex Aspheric, Aspheric Intraocular Lenses | Rayner Intraocular Lenses Ltd. East Sussex United Kingdom BN3 7AN |
Approval for modifications to the tumbling process. |
| P060025/S014 10/13/15 180-Day |
ATS 3f Aortic Bioprosthesis | Medtronic, Inc. Lake Forest, CA 92630 |
Approval of the post-approval study protocol. |
| P060037/S038 10/6/15 135-Day |
Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee | Zimmer, Incorporated Warsaw, IN 46581 |
Approval for automating the final cleaning process for NexGen LPS-Flex/LPS Mobile Bearing Knee System components, and introducing a new cleaning detergent for tibial components. |
| P060038/S025 10/12/15 Real-Time |
Mitroflow Aortic Pericardial Heart Valve | Sorin Group Canada, Inc. Burnaby, BC Canada V5J 5M1 |
Approval for extending the shelf life for the device from one year to two years. |
| P060040/S046 10/19/15 Special |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Approval for revisions to the Instructions for Use regarding checking the expiration date of and replacing the backup battery contained on the Pocket Controller. |
| P080009/S007 10/6/15 Real-Time |
SEDASYS Computer-Assisted Personalized Sedation System | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Approval for software changes to resolve three anomalies. |
| P080009/S009 10/8/15 Special |
SEDASYS® Computer-Assisted Personalized Sedation System | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Approval for changes to the clinical user guide/ operator’s manual to warn against the use of quaternary ammonium compound (QAC)-based disinfectants (specifically those containing ammonium chlorides). Additionally, affixing two labels to the exterior of the device which reiterate this warning. |
| P080026/S016 10/9/15 Real-Time |
RealTime HBV | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid. |
| P090012/S004 10/22/15 135-Day |
Melafind | MELA Sciences Incorporated Irvington, NY 10533 |
Approval for a change in the cart high potential (HI-POT) breakdown test sequence and the release of hand-held imager HI-POT breakdown test procedure. |
| P090013/S165 10/19/15 180-Day |
Revo MRI | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Remote Control Software on the 2090 Programmer. |
| P090013/S198 10/7/15 Real-Time |
Revo MRI SureScan IPG | Medtronic Inc. Mounds View, MN 55112 |
Approval for the firmware updates for the home monitor systems, which will be used with the implantable devices. |
| P100006/S001 10/5/15 Real-Time |
Augment® Bone Graft | BioMimetic Therapeutics, Inc. Franklin, TN 37067 |
Approval for proposed edits to the package insert. |
| P100017/S014 10/9/15 Real-Time |
RealTime HCV | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid. |
| P100022/S016 10/26/15 135-Day |
Zilver® PTX® Drug-Eluting Peripheral Stent | Cook Medical Incorporated Bloomington, IN 47402 |
Approval for the addition of a stent reclaim process. |
| P100034/S013 10/5/15 Panel-Track |
Optune™ (Formerly the NovoTTF-100A System) | Novocure, Ltd. Haifa, Israel |
Approval for the Optune (formerly the NovoTTF-100A System). This device is indicated as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy. Optune was previously approved in 2011 for the treatment of recurrent GBM with the following Indications for Use (IFU): Optune™ is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. |
| P100040/S021 10/30/15 180-Day |
Valiant Thoracic Stent Graft with the Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for an update to the Valiant Thoracic Stent Graft with Captivia Delivery System’s Instructions for Use (IFU) to include the VALOR II post approval study data. |
| P100041/S055 10/19/15 135-Day |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier. |
| P110002/S010 10/6/15 180-Day |
Mobi-C® Cervical Disc Prosthesis | LDR Spine USA, Incorporated Austin, TX 78750 |
Approval for modifications to the Mobi-C labeling. |
| P110009/S010 10/6/15 180-Day |
Mobi-C® Cervical Disc Prosthesis | LDR Spine USA, Incorporated Austin, TX 78750 |
Approval for modifications to the Mobi-C labeling. |
| P110021/S042 10/19/15 135-Day |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier. |
| P110033/S15 10/6/15 Real-Time |
Juvéderm Voluma XC | Allergan Irvine, CA 92623 |
Approval for an improvement to the method used to measure HA content of final JUVÉDERM and VOLUMA XC products during batch release. |
| P120004/S001 10/16/15 180-Day |
Parascript® AccuDetect® 7.0 | Parascript, LLC Longmont, CO 80503 |
Approval for Parascript AccuDetect version 7.0. |
| P120010/S001 10/2/15 135-Day |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Approval for adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (GOx) performed by the supplier for use in the sponsor’s Enlite Sensor (Model: MMT-7008) and Sof-Sensor (Models: MMT-7002 and MMT-7003) Devices. The Enlite Sensor is a component of the MiniMed 530G System. The Sof-Sensor is a component of the Paradigm REAL-Time, Paradigm REALTime Revel, Guardian REAL-Time, MiniLink REAL-Time, IPro Recorder and IPro2 Professional Continuous Glucose Monitoring systems. |
| P120010/S046 10/2/15 Panel-Track |
MiniMed 530G System with Threshold Suspend featuring SmartGuard™ Technology | Medtronic, Inc. Northridge, CA 91325 |
Approval for the MiniMed 530G System with Threshold Suspend featuring SmartGuard technology. This device is indicated for the following: The MiniMed 530G System is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G System can be programmed to automatically suspend delivery of insulin when the sensor glucose value falls below a predefined threshold value. The MiniMed 530G System consists of the following devices that can be used in combination or individually: MiniMed 530G Insulin Pump, Enlite Sensor, Enlite Serter, the MiniLink Real-Time System, the Bayer Contour NextLink glucose meter, CareLink Professional Therapy Management Software for Diabetes, and CareLink Personal Therapy Management Software for Diabetes. The system requires a prescription. The MiniMed 530G System is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 530G System. The MiniMed 530G System is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm to take measures to prevent or treat hypoglycemia himself. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s Health Care Provider. |
| P120012/S009 10/9/15 Real-Time |
RealTime HCV Genotype II | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for two changes to the application specification files to extend the chiller delay timer and change the conductivity setting for the detection of RNA Wash2 liquid. |
| P120024/S001 10/21/15 Real-Time |
activL® Artificial Disc | Aesculap Implant Systems, LLC Center Valley, PA 18034 |
Approval for changes to the activL instrument trays. |
| P130006/S020 10/14/15 180-Day |
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86005 |
Approval for a Post-Approval Study labeling update regarding revisions to the Instructions for Use to include the final study results for the RELINE Extended Follow-Up Study. |
| P130007/S003 10/30/15 135-Day |
Animas Vibe System | Animas Corporation West Chester, PA 19380 |
Approval for a change to the manufacturing location and process for spray paint coating of the Animas Vibe insulin pump outer plastic base and cover. The Animas Vibe insulin pump is a component of the Animas Vibe System. |
| P130007/S008 11/3/15 Real-Time |
Animas® Vibe™ System | Animas Corporation West Chester, PA 19380 |
Approval for replacing the flash memory of the Printed Circuit Board Assembly (PCBA) used in the Animas® VibeTM Insulin Pump, a component of the Animas® Vibe System, as well as subsequent software changes. |
| P130009/S004 10/19/15 135-Day |
Edwards SAPIEN XT Transcatheter Heart Valve; Edwards Qualcrimp Crimping Accessory |
Edwards Lifesciences, LLC. Irvine, CA 92614 |
Approval for a manufacturing line change and the use of ammonium perfluorooctanoate (APFO) free resin at Lenzing Plastics GmbH, an Edwards approved supplier. |
| P130009/S034 10/9/15 Panel-Track |
Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories, (NovaFlex+ Delivery System with Crimp Stopper and Qualcrimp Crimping Accessory Laminated or Cloth, Edwards Expandable Introducer sheath Set, Ascendra+ delivery system with crimp stopper, Ascendra+ Introducer Sheath Set, and Edwards Crimper |
Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for the SAPIEN XT Transcatheter Heart Valve, Model 9300TFX, and Accessories. This device is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days). |
| P140018/S001 10/7/15 Real-Time |
VenaSeal Closure System | Covidien Plymouth, MN 55441 |
Approval for the use of a single sterile barrier packaging system for the VenaSeal Closure System, in place of the double sterile barrier system |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N18033/S079 10/15/15 |
VISTAKON (etafilconA) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Changes to the supplier of the mold material. |
| N970012/S112 10/30/15 |
AMS 700 Inflatable Penile Prosthesis | Boston Scientific, Inc. Minnetonka, MN 55343 |
Changes in the fabric wash process water level range, the rinse cycle pH testing, and the inspection of cut fabric angle measurement. |
| P830061/S122 10/2/15 |
Capsure and Vitatron Lead Models | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P840001/S313 10/14/15 |
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimulation Leads | Medtronic, Inc. Minneapolis, MN 55432 |
New laser welding equipment for the spinal cord stimulation (SCS) and deep brain stimulation (DBS systems). |
| P840001/S314 10/30/15 |
External Neurostimulator; Itrel 4 Programmable Neuro-stimulator for Spinal Cord Stimulation; RestorePrime Neurostimulator; PrimeAdvanced Neurostimulator; RestoreUltra Neurostimulator; RestoreAdvanced Neurostimulator; RestorSensor Neurostimulator; PrimeAdvanced SureScan MRI Neurostimulator; RestoreUltra SureScan MRI Rechargeable Neurostimulator; RestoreAdvanced SureScan MRI Rechargeable Neurostimulator; RestoreSensor SureScan MRI Rechargeable Neurostimulator | Medtronic Inc. Minneapolis, MN 55432 |
Update the manufacturing execution system (MES) at Medtronic Tempe Campus (MTC) in Tempe, Arizona. |
| P850079/S068 10/15/15 |
Methafilcon A and B Soft (hydrophilic) Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Change in material (FINA) for the blister packaging and new supplier for this material. |
| P860004/S237 10/21/15 |
SynchroMed Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of Medtronic Puerto Rico Operations Co. in Juncos, Puerto Rico. |
| P860004/S238 10/30/15 |
SynchroMed II Infusion System | Medtronic Inc. Minneapolis, MN 55432 |
To update the manufacturing execution system (MES) at Medtronics hybrid supplier, Medtronic Tempe Campus (MTC) in Tempe, Arizona. |
| P860057/S139 10/27/15 |
Carpentier-Edwards PERIMOUNT Pericardial Aortic Mitral Bioprostheses | Edwards Lifesciences, LLC Irvine, CA 92614 |
The addition of a terminal liquid sterilization oven. |
| P890003/S337 10/2/15 |
Vitatron Brilliant S+VDD Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P890055/S061 10/8/15 |
Codman 3000 Constant-Flow Infusion Pump & MedStream Programmable Infusion System Accessories | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Changes to the sterilization process: 1) Steam injection rate currently at 20 mbar/min will change to 5 mbar/min; 2) Gas injection rate currently at 25 mbar/min will change to 20 mbar/min; 3) Minimum primary degassing time of 10 hours will change to 8 hours; 4) The handles from the sterilization shipper, number 197548018, will be removed; 5) Add a second Ethylene Oxide (EO) Sterilization Chamber (Chamber #4; 6) A minimum EO sterilization load in Chamber #3 (existing chamber) and Chamber #4; and 7) A 2X EO sterilization for both Chamber #3 and #4. |
| P900056/S151 10/13/15 |
Rotoblator Rotational Angioplasty System Guidewire | Boston Scientific Corporation Maple Grove, MN 55311 |
The addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer. |
| P900061/S137 10/2/15 |
End Cap, Upsizing Sleeve | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P910023/S363 10/7/15 |
Current+ DR, Current+ VR, Ellipse DR, Ellipse VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR | St. Jude Medical Sylmar, CA 91342 |
Addition of an alternate feedthru supplier for high voltage capacitors utilized in the devices. |
| P920015/S162 10/2/15 |
Sprint Quattro Leads, Subcutaneous Lead, Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P920015/S165 10/30/15 |
Sprint Quattro Lead | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing transfer to a different internal supplier for the Dexamethasone Acetate (DXAC) Monolithic Controlled Release Device (MCRD) component used in the device. |
| P920047/S085 10/1/15 |
Blazer II, Blazer II HTD, Blazer Prime HTD | Boston Scientific Corporation San Jose, CA 95134 |
Increased capacity shipping cartons and an increased pallet configuration. |
| P920047/S086 10/13/15 |
Blazer II Cardiac Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer. |
| P930039/S137 10/2/15 |
SureFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P930039/S139 10/7/15 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead | Medtronic, Inc. Mounds View, MN 55112 |
Welding process change, from a manual welding process to a semi-automated welding process for the Hedix Subassembly of the lead systems. |
| P930039/S141 10/30/15 |
CapSureFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing transfer to a different internal supplier for the Dexamethasone Acetate (DXAC) Monolithic Controlled Release Device (MCRD) component used in the device. |
| P950024/S065 10/2/15 |
CapSure Epicardial Pacing Leads | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P960004/S074 10/13/15 |
FINELINE II STEROX Lead Endocardial Suture Sleeve Accessory | Boston Scientific Corporation St. Paul, MN 55112 |
Insourcing Boston Scientific Corporation as a manufacturer for the molded silicone slit suture sleeve accessory. |
| P960009/S238 10/14/15 |
Activa Deep Brain Stimulation Therapy System | Medtronic, Inc. Minneapolis, MN 55432 |
New laser welding equipment for the spinal cord stimulation (SCS) and deep brain stimulation (DBS systems). |
| P960009/S239 10/30/15 |
External Neurostimulator; Activa PC Neurostimulator; Activa SC Neurostimulator; Activa RC Neurostimulator | Medtronic Inc. Minneapolis, MN 55432 |
Update the manufacturing execution system (MES) at Medtronic Tempe Campus (MTC) in Tempe, Arizona. |
| P960016/S057 10/21/15 |
Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter` | St. Jude Medical St. Paul, MN 55147 |
Remove a redundant run-in test for the Ampere system from the manufacturing process. |
| P960022/S011 10/19/15 |
Bausch & Lomb Soflens Toric (alphafilcon A) Contact Lens | Bausch & Lomb, Inc. Rochester, NY 14609 |
Qualifying an alternate supplier of a critical raw material component for the Bausch & Lomb Soflens Toric (alphafilcon A) contact lens. |
| P960040/S355 10/7/15 |
Incepta ICD, Energen ICD, Punctua ICD, Dynagen ICD, Inogen ICD, Origen ICD, | Boston Scientific Corporation St. Paul, MN 55112 |
Manufacture the spring connector block housing components for the referenced pulse generators at Boston Scientific Corporation facility, St. Paul, Minnesota. |
| P960040/S356 10/19/15 |
ORIGEN EL ICD, ORIGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, | Boston Scientific Corporation St. Paul, MN 55112 |
Convert one Super Output Module (SOM) to another SOM by subjecting it to a temperature cycle screening process. |
| P960040/S357 10/21/15 |
PUNCTUA, ENERGEN, INCEPTA, ORIGEN INOGEN, DYNAGEN | Boston Scientific Corporation St. Paul, MN 55112 |
Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the devices. |
| P970004/S205 10/30/15 |
InterStim II Neurostimulator | Medtronic Inc. Minneapolis, MN 55432 |
Update the manufacturing execution system (MES) at Medtronics hybrid supplier, Medtronic Tempe Campus (MTC), Tempe, Arizona. |
| P970021/S043 10/2/15 |
GYNECARE THERMACHOICE III Uterine Balloon Therapy System | Ethicon, Inc. Somerville, NJ 08876 |
Changes to the manufacturing process, Process Specification For Drive Assembly, Thermachoice Catheters 3.0, for the GYNECARE THERMACHOICE Balloon Catheter. |
| P970051/S134 10/14/15 |
Nucleus CI512 and CI522 Cochlear Implant | Cochlear Americas Centennial, CO 80111 |
Addition of rework and inspection steps to manufacturing procedures at the Macquarie manufacturing facility. |
| P980003/S064 10/13/15 |
Chilli II Cooled Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer. |
| P980016/S549 10/14/15 |
Evera MRI XT DR SureScan ICD, Evera MRI XT VR SureScan ICD, Evera MRI S DR SureScan ICD, Evera MRI S VR SureScan ICD | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing changes: Expansion of a controlled environment area, Addition of a laser welding system, Update to hybrid tracking during manufacturing, Connector molding manufacturing process change, Addition of a soak oven temperature verification, and Implementation of a continuous monitoring system. |
| P980016/S552 10/23/15 |
Evera MRI ICD; Evera DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Maximo II ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging. |
| P980016/S553 10/22/15 |
Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes. |
| P980016/S554 10/29/15 |
Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD | Metronic, Inc. Mounds View, MN 55112 |
Change to the high voltage capacitor weld monitoring frequency. |
| P980035/S440 10/23/15 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging. |
| P980035/S441 10/22/15 |
Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Update the manufacturing execution system (MES) to ACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes. |
| P980037/S049 10/30/15 |
AngioJet Thrombectomy System | Boston Scientific Corporation Minneapolis, MN 55433 |
Change in the bioburden assessment. |
| P000012/S054 10/15/15 |
COBAS AMPLICOR Hepatitis C Virus Test version 2.0 and COBAS AmpliPrep/COBAS AMPLICOR HCV Test version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Elimination of an in-process functional test for a final component. |
| P000037/S043 10/5/15 |
On-X Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78752 |
The addition of a Coordinate Measuring Machine. |
| P010012/S400 10/7/15 |
Incepta ICD Energen ICD, Punctua ICD, Dynagen ICD, Inogen ICD, Origen ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Manufacture the spring connector block housing components for the referenced pulse generators at Boston Scientific Corporation facility in St. Paul, Minnesota. |
| P010012/S401 10/19/15 |
ORIGEN CRT-D, ORIGEN X4 CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D | Boston Scientific Corporation St. Paul, MN 55112 |
Convert one Super Output Module (SOM) to another SOM by subjecting it to a temperature cycle screening process. |
| P010012/S402 10/21/15 |
PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN |
Boston Scientific Corporation St. Paul, MN 55112 |
Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the device models. |
| P010015/S280 10/2/15 |
Attain Bipolar OTW Lead, Attain OTW LV Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P010015/S282 10/22/15 |
Consulta CRT-P; Syncra CRT-P; Viva CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes. |
| P010019/S041 10/13/15 |
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear (NIGHT & DAY, AIR OPTIX NIGHT & DAY AQUA, O2OPTIX, AIR OPTIX AQUA, AIR OPTIX for ASTIGMATISM, AIR OPTIX AQUA MULTIFOCAL) | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Introduce an alternate source of isopropyl alcohol. |
| P010030/S066 10/2/15 |
LifeVest Wearable Defibrillator-Model WCD 4000 | ZOLL Manufacturing Corporation Pittsburgh, PA 15238 |
Alternate supplier, Sun Star, Inc., in Latrobe, Pennsylvania for the ECG backcover with retainer dual and ECG back cover with retainer single. |
| P010031/S514 10/22/15 |
Brava CRT-D; Brava Quad CRT-D; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes. |
| P010031/S515 10/23/15 |
Brava CRT-D; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging. |
| P010031/S516 10/29/15 |
Brava CRT-D; Brava Quad CRT-D; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Change to the high voltage capacitor weld monitoring frequency. |
| P010032/S101 10/15/15 |
Tripole, Tripole 16c, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitrode winged, Lamitrode, Penta, Quattrode, Octrode, Dual 4 Extension, Single 8 Extension, A127 Extension, 8 Channel Adapters, Compustim Adapter | St. Jude Medical Neuromodulation Plano, TX 75024 |
Implementation of a change to the tumbling process of electrodes used on the SCS leads, extensions, and adapters. |
| P020025/S079 10/1/2015 |
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP | Boston Scientific Corp. San Jose, CA 95134 |
Increased capacity shipping cartons and an increased pallet configuration. |
| P020025/S080 10/13/15 |
Blazer II XP Cardiac Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a vacuum pump anti-surge device to the existing Chamber 1 equipment at the contract sterilizer. |
| P020047/S063 10/22/15 |
Multi-Link Vision, Multi-Link Mini-Vision, and Multi-Link 8 Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
Change to the stent process monitoring system. |
| P030011/S035 10/29/15 |
SynCardia temporary Total Artificial Heart (TAH-t) System | SynCardia Systems, Inc. Tucson, AZ 85713 |
Alternate assembler for certain Freedom Driver printed circuit board assemblies. |
| P030017/S236 10/9/15 |
Precision Spectra Spinal Cord Stimulator (SCS) System | Boston Scientific Corp. Valencia, CA 91355 |
Process change to the welding process for attaching the battery to the Kovar tabs on the printed circuit board assembly (PCBA) during the manufacture of Implantable Pulse Generator (IPG) devices. |
| P030017/S237 10/22/15 |
Precision Spectra Cord Stimulator (SCS) System | Boston Scientific Corporation Valencia, CA 91355 |
Implementation of an update to the test equipment system and associated software used for testing Continuity and HiPot on the Artisan (2X8) Surgical (Paddle) Lead and CoverEdge 32 Contact Surgical (Paddle) Leads. |
| P030054/S293 10/7/15 |
Promote+, Quadra Assura Unify, Unify Assura, Unify Quadra | St. Jude Medical Sylmar, CA 91342 |
Addition of an alternate feedthru supplier for high voltage capacitors utilized in the devices. |
| P040014/S027 10/21/15 |
Therapy Ablation Catheters | St. Jude Medical St. Paul, MN 55147 |
Remove a redundant run-in test for the Ampere system from the manufacturing process. |
| P040042/S032 10/21/15 |
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters | St. Jude Medical St. Paul, MN 55147 |
Remove a redundant run-in test for the Ampere system from the manufacturing process. |
| P040047/042 10/1/15 |
COAPTITE Injectable Implant for the treatment of Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency in Adult Females | Merz North America Franksville, WI 53126 |
Lifting the requirement that manufacturing equipment remain dedicated to specific products. |
| P050037/S062 10/1/15 |
RADIESSE Injectable Implant | Merz North America Franksville, WI 53126 |
Lifting the requirement that manufacturing equipment remain dedicated to specific products. |
| P050047/S051 10/23/15 |
Juvederm Hyaluronate Gel Implants | Allergan Irvine, CA 92612 |
Implementation of an automated visual inspection process and accompanying in-process control for inspecting the 0.8 mL syringe configuration of Juvederm Hyaluronate Gel Implants. |
| P050052/S072 10/1/15 |
RADIESSE Injectable Implant | Merz North America Franksville, WI 53126 |
Lifting the requirement that manufacturing equipment remain dedicated to specific products. |
| P060019/S034 10/21/15 |
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters | St. Jude Medical St. Paul, MN 55147 |
Remove a redundant run-in test for the Ampere system from the manufacturing process. |
| P060037/S040 10/2715 |
Zimmer Nexgen LPS-Flex Mobile and LPS Mobile Bearing Knee System | Zimmer, Incorporated Warsaw, IN 46581 |
Add a new contract laboratory to increase biological indicator verification testing capacity for the LPS mobile tibial articular surface components. |
| P060040/S044 10/14/15 |
Thoratec Heartmate II Left Ventricular Assist System (lvas) | Thoratec Corporation Pleasanton, CA 94588 |
Addition of an alternate supplier for a critical component in the HeartMate II LVAS Pocket Controller. |
| P070015/S131 10/22/15 |
XIENCE V and nano Everolimus Eluting Coronary Stent Systems | Abbott Vascular Inc. Temecula, CA 92589 |
Change to the stent process monitoring system. |
| P070027/S045 10/15/15 |
Talent Occluder with Occluder Delivery System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Implementation of a new Internal Process Challenge Device (IPCD) inoculation method for biannual sterilization requalification. |
| P070027/S046 10/23/15 |
Talent Occluder with Occluder Delivery System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Change in the inoculation process site for sterilization requalification. |
| P080006/S084 10/2/15 |
Attain Ability Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P080025/S100 10/30/15 |
InterStim II Neurostimulator | Medtronic Inc. Minneapolis, MN 55432 |
To update the manufacturing execution system (MES) at Medtronics hybrid supplier, Medtronic Tempe Campus (MTC) in Tempe, Arizona. |
| P080027/S021 10/15/15 |
OraQuick HCV Rapid Antibody Test | OraSure Technologies, Inc. Bethlehem, PA 18015 |
Update to weld parameters and modifications to automated welding equipment. |
| P090006/S016 10/20/15 |
Complete SE Vascular Stent System – Iliac | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Changes to the manufacturing equipment used in assembly of the Complete SE Vascular Stent System. |
| P090013/S199 10/2/15 |
CapSureFix MRI Lead Model 5086MRI | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P090013/S201 10/7/15 |
CapSureFix MRI Lead 5086MRI | Medtronic, Inc. Mounds View, MN 55112 |
Welding process change, from a manual welding process to a semi-automated welding process for the Hedix Subassembly of the lead systems. |
| P090013/S203 10/23/15 |
Revo MRI SureScan IPG Model RVDR01 | Medtronic, Inc. Mounds View, MN 55112 |
Removal of various visual inspections and re-ordering of steps in the work instructions implemented in the automatic line of final packaging. |
| P090013/S204 10/22/15 |
Revo MRI SurScan IPG | Medtronic, Inc. Mounds View, MN 55112 |
Update the manufacturing execution system (MES) to FACTORY works 9.1, iMPM MES Web Services 3.0.0, and other associated changes. |
| P100009/S013 10/15/15 |
Mitraclip Clip Delivery System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Changes to the cleanroom classification. |
| P100009/S014 10/29/15 |
Mitraclip Clip Delivery System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Changes to the connector manufacturing process. |
| P100044/S019 10/28/15 |
Propel and Propel Mini Sinus Implants | Intersect ENT Menlo Park, CA 94025 |
Adding an incoming quality assurance test for shrinkage of the fiber components of the Propel and Propel Mini products and to increase the upper limit for the Inherent Viscosity (IV) manufacturing lot release specification to match the upper limit for the current IV design specification. |
| P110004/S014 10/1/15 |
NIRxcell CoCr Coronary Stent On Rx System | Medinol Ltd. Tel-Aviv, Israel 615801 |
Change to stent welding equipment. |
| P110006/S006 10/15/15 |
Invenia ABUS – Automated Breast Ultrasound System | U-Systems Inc., a GE Healthcare Company Sunnyvale, CA 94085 |
Changes in suppliers for 12 critical parts, to improve the parts’ quality, productivity, and delivery. The common characteristic of all 12 parts is their electrical conductivity on specified surfaces, to allow electrical continuity for proper grounding of the device. The proposed changes do not involve any changes in the design or manufacturing process of the device. |
| P110016/S023 10/21/15 |
FlexAbility Ablation Catheter | St. Jude Medical St. Paul, MN 55147 |
Remove a redundant run-in test for the Ampere system from the manufacturing process. |
| P110019/S078 10/22/15 |
Xience Prime Everolimus Eluting Coronary Stent System, and Xience Prime II Everolimus Eluting Coronary Stent System | Abbott Vascular Inc. Temecula, CA 92589 |
Change to the acceptance sampling system for dislodgement testing for the XIENCE PRIME and XIENCE PRIME II Everolimus Eluting Coronary Stent System. |
| P110019/S079 10/22/15 |
XIENCE PRIME, Xpedition, and Alpine Everolimus Eluting Coronary Stent Systems | Abbott Vascular Inc. Temecula, CA 92589 |
Change to the stent process monitoring system. |
| P110040/S008 10/20/15 |
Complete SE Vascular Stent System – SFA/PPA | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Changes to the manufacturing equipment used in assembly of the Complete SE Vascular Stent System. |
| P110042/S050 10/7/15 |
Emblem Subcutaneous Implantable Cardiac Defibrillator (S-ICD) Model A209 | Boston Scientific Corporaton St. Paul, MN 55112 |
Manufacture the spring connector block housing components for the referenced pulse generators at Boston Scientific Corporation facility in St. Paul, Minnesota. |
| P110042/S051 10/19/15 |
EMBLEM S-ICD Pulse Generator | Boston Scientific Corporation St. Paul, MN 55112 |
Change to the radii profile measurement method for the front and back cases of the device. |
| P110042/S052 10/21/15 |
PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN | Boston Scientific Corporation St. Paul, MN 55112 |
Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the referenced device models. |
| P120005/S039 10/23/15 |
Dexcom G4 PLATINUM Continuous Monitoring Sysem; Dexcom G5 Mobile Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Removal of an in-process inspection testing performed during the manufacturing process of the G4 Platinum and G5 Mobile transmitters. The G4 PLATINUM and the G5 Mobile transmitters are components of the G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System, respectively. |
| P120017/S001 10/2/15 |
Myocardial Pacing | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of new serial number printing software within the existing traceability system. |
| P130007/S009 10/21/15 |
Animas Vibe System | Animas Corporation West Chester, PA 19380 |
Transferring the Glucose Engine Radio Frequency Board Assembly (GE Assembly) screening testing to the supplier. The GE Assembly is a component of the Animas Vibe System. |
| P130009/S041 10/27/15 |
Edwards Sapien XT Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
The addition of a terminal liquid sterilization oven. |
| P130022/S001 10/2/15 |
Senza Spinal Cord Stimulation System | Nevro Corporation Menlo Park, CA 94025 |
Modification in the manufacturing process of the connector stack sub-assembly. |
| P130026/S010 10/21/15 |
TactiCath Quartz Catheter and TactiSysQuartz Equipment | St. Jude Medical St. Paul, MN 55147 |
Remove a redundant run-in test for the Ampere system from the manufacturing process. |
| P140010/S010 10/15/15 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Automated vision inspection system. |
| P140015/S001 10/8/15 |
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM | Tandem Diabetes Care, Inc. San Diego, CA 92121 |
Add a second insulin cartridge assembly production line. The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM. |
| P140015/S002 10/8/15 |
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM | Tandem Diabetes Care, Inc. San Diego, CA 92121 |
Addition of a second cartridge laser weld subassembly production line. The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM. |
| P140015/S003 10/8/15 |
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM | Tandem Diabetes Care, Inc. San Diego, CA 92121 |
Addition of a second insulin Cartridge Test System (CTS). The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM. |
| P140015/S004 10/8/15 |
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM | Tandem Diabetes Care, Inc. San Diego, CA 92121 |
Addition of a second head-to-bag insulin cartridge subassembly test system. The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM. |
| P140015/S005 10/15/15 |
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM | Tandem Diabetes Care, Inc. San Diego, CA 92121 |
Removal of a non-destructive test and a move of an existing destructive test to an earlier point in the manufacturing process of the t:slim insulin cartridge. The insulin cartridge is a disposable component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM. |
| P140028/S002 10/2/15 |
Innova Vascular Self-Expanding Stent with Delivery System | Boston Scientific Corp. Maple Grove, MN 55311 |
Addition of an optional oxide removal step during a manufacturing inspection. |
| P140028/S003 10/23/15 |
Innova Vascular Self-Expanding Stent With Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Equipment updates associated with the Innova stent process. |
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